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Re: dennisdave post# 799205

Friday, 11/21/2025 5:00:21 PM

Friday, November 21, 2025 5:00:21 PM

Post# of 819827
dennis. I think you are missing the point some of us are making. Flaskworks/Eden will be future of manufacturing for NWBO/Advent. This "upgrade" can take place at any time once every thing is in place and NWBO can file a amendment. It doesnt have to be added to the r/gbm MAA that is currently under review. They have enough B space to handle GBM demand right now. This what we are saying. I highly doubt NWBO would delay the current MAA for another 6-8 months. Sure, NICE wont reimburse as is (manual), nobody is arguing that. But why would NWBO delay approval when Flaskworks can be validated once its completed? MHRA doesn't require NW to have Flaskworks up and running. It really doesnt matter if they file for it now, or when completed with the C build-out. In fact, during my convo with GZ, I think approval is getting very close. You are free to believe anything you want, as you were free to believe Flaskworks was dead not too long ago and your "sources" stated approval was last Feb. Your track record is not good.

Question: Have you spoken to GZ at all?
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